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Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Eligibility criteria shortened, about 16 words · Secondary endpoints: details revised at 1 of 6 entries · Site details revised at 5 of 5 sites Show 3 more changesShow less
    • Eligibility criteria shortened, about 16 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised at 5 of 5 sites
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2026 Completion date: Mar 31, 2026 to Mar 31, 2027 · Eligibility criteria expanded, about 16 words · Site details revised at 3 of 5 sitesv11 Show 3 more changesShow less
    • Completion date: Mar 31, 2026 to Mar 31, 2027
    • Eligibility criteria expanded, about 16 words
    • Site details revised at 3 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 4 to 5v10
  4. Re-verified, no change to tracked fieldsv9
  5. Eligibility criteria shortened, about 7 wordsv8 See this version in full on ClinicalTrials.gov ↗
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Aug 7, 2024 to Dec 31, 2025 Study sites: 3 to 4 · Completion date: Sep 24, 2024 to Mar 31, 2026 · Eligibility criteria shortened, about 32 words · 1 morev7 Show 4 more changesShow less
    • Study sites: 3 to 4
    • Completion date: Sep 24, 2024 to Mar 31, 2026
    • Eligibility criteria shortened, about 32 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 91 wordsv6 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv5
  4. Site details revised at 1 of 3 sitesv4
  5. Site contacts updated at 1 of 3 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 11, 2022 to May 31, 2022 · Site details revised at 3 of 3 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 11, 2022 to May 31, 2022
    • Site details revised at 3 of 3 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multiple center, non-randomized, open-label, phase 1/2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).
Trial Details
NCT Number NCT05326243
Lead Sponsor Pell Bio-Med Technology Co., Ltd.
Conditions Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Large B-cell Lymphoma, Follicular Lymphoma Grade 3A, Follicular Lymphoma Grade 3B
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov